PROVIDENCE – Investigators at Rhode Island Hospital, a Lifespan facility, are recruiting volunteers for a national multicenter clinical trial of a new and highly innovative approach treating people with early Alzheimer’s disease, RIH reported recently. This immunotherapy – an antibody drug – against the tau protein, which builds up in the cells of individuals who have Alzheimer’s disease, is produced by AbbVie, a global pharmaceutical company.
Before symptoms of Alzheimer’s appear, two proteins – tau and amyloid – are accumulating in the brains of individuals with the disease. When tau and amyloid build up, together, they may interfere with the brain’s normal functions and may cause memory and thinking problems. AbbVie’s immunotherapy, ABBV-8E12, attaches to the tau protein and attempts to keep it from spreading through the brain and collecting in brain cells.
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A special type of brain scan, an amyloid Positron Emission Tomography scan enables researchers to view amyloid in the brain of a living patient. Only individuals with higher levels of amyloid plaques on their PET scan will qualify to participate in this study, reported RIH.
“Because changes in tau are more closely related to the degeneration of nerve cells as well as the symptoms of Alzheimer’s disease, we are hopeful that this will be a successful approach to controlling the disease,” Dr. Brian Ott, principal investigator at Rhode Island Hospital, said in the statement. “Among investigational drugs currently under study for [Alzheimer’s disease], ABBV-8E12 is unique in that it does not aim to reduce amyloid protein buildup in the brain, but is the first immunotherapy to target tau protein.”
The amount of tau protein in the brain is estimated by testing the spinal fluid (cerebrospinal fluid that is sometimes referred to as CSF) bathing the brain and spinal cord. In this study, expected to last 24 months, ABBV-8E12 will be administered intravenously approximately once each month, Lifespan reported. Three of every four study participants will receive the immunotherapy drug being studied, while one will receive a saltwater placebo injection. Each individual joining this study must have a study partner who can attend some of the study visits.
Ott, who directs the Alzheimer’s Disease and Memory Disorders Center, also oversees other clinical trials related to Alzheimer’s disease treatments, including the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease, on which Providence Business News reported in early May 2016.
Individuals interested in volunteering for this new clinical trial may contact Ott or Dr. Lori Daiello at the Alzheimer’s Disease and Memory Disorders Center at (844) 563-6679 or memory@lifespan.org.
